SYNTHESIS AND CHARACTERIZATION OF FIVE IMPURITIES OF RANOLAZINE

Shebin John*, Pramila T. and Bhavana R.

ABSTRACT

Ranolazine (Ranexa) is a piperazine derivative, used as a second-line treatment in patients with stable or poorly controlled chronic angina and unresponsive to other drugs. Five known impurities of ranolazine were synthesized individually and characterization of these five impurities were done using the spectral data (IR, NMR and mass). The structure of all five impurities were assigned as N-(2,6-dimethylphenyl)-2-(piperazin-1-yl) acetamide, 4-(2-methoxyphenoxy) butane-1,3-diol, 2,2'-(4,4'-(2-hydroxypropane-1,3-diyl) bis(piperazine-4,1-diyl)) bis(N-(2,6-dimethylphenyl) acetamide), 2-((2-methoxyphenoxy) methyl) oxirane and N-(2,6-dimethylphenyl)-2-(4-(2-hydroxy-3-(4-methoxyphenoxy) propyl) piperazin-1-yl) acetamide respectively. The present work describes synthesis and characterization of these impurities of ranolazine.

Keywords: Characterization, Impurities, Ranolazine, Synthesis.